Job Description :
Job Code : Domain
Primary Skill : Pharma
Role : Labelling Lead
City : West Chester
State : Pennsylvania
Country : United States

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Skill Description Skill Type Min Exp(months) Max Exp(months)
Pharma PRIMARY 72 84
Job description :

S. /M.S. in Engineering or equivalent with 7+years of experience in Life sciences ? Pharma/ Medical Devices processes / projects especially in Product Labeling
? Strong knowledge in Medical Devices Labeling/Content Management

SPOC between client and Syntel team
? Understanding and mapping of current labeling process, tools and systems
? Understand and gather labeling needs of the client
? Identification of gaps with respect to regulatory standards, standard industry practices and client requirements
? Provide SME support to the business stakeholders for labeling solution
? Provide Labeling Platform Technical expertise and identify labeling tool and technology to suit the Business Requirements
? Follow up with SMEs and stakeholders to ensure timely inputs and approvals
? Understanding Global Regulatory requirements of Medical Devices/Pharma Labeling
? Coordinate with Project Manager / Lead / Client & get trained in client requirement software(s) and applicable standards
? Knowledge of designing and printing of labels used on finished goods product ensuring that they meet business and industry regulations
? Work closely with project leaders in the creation, design and implementation of product labeling and packaging graphics
? Work closely with outside services such as translation houses, service bureaus, design houses and consultants as needed.
? Develop/create artwork/graphics/symbols/images for product labeling and packaging graphics
? Create documentation packages & Change Management for artwork/label approval & release
? Create and maintain proofing packet documentation for the project like From-Tos, Checklists etc.
? Creation of checklists, SOPs, work instructions, labeling procedures
? Create & validate Templates/labels
? Manage Design execution from start of design through to production.
? QA for Labeling & change management processes
? Proactively communicate project status, issues & risk to management.
? Create/Modify/Revise labels using PRISYM Medica software
? Create and route COs using current PLM system